SUPPLY CHAIN ARTICLES
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Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward
Overall, my presentation on what the mRNA industry can learn from the artist Picasso singled out a few specific areas from which I felt our industry could garner greater inspiration and operational prowess. But given how “collaborative” many of these sources of inspiration are, I’ve introduced each of my takeaways with a surprisingly relevant (albeit bad) art-themed pick-up line. After all, if there’s one sector that knows it takes more than one to “tango,” it’s the mRNA industry.
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Assessing Quality Of mRNA Vaccines: Key Considerations
To address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.
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FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
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Beyond The Gold Standard(s): Modernizing Oligonucleotide Synthesis
A few weeks ago, I had the chance to sit down with OPT Congress speaker Phil Baran, Richard Lerner Chair Professor, Department of Chemistry, Scripps Research. Baran was slated to (and did) present a keynote on the innovations shaping the next generation of oligo synthesis. Here, I share the biggest takeaways I had from our conversation, touching on how he sees the science of oligo chemistry and manufacturing advancing in the near and far future.
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Can America's Retreat On mRNA Be Europe's Opportunity?
With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.
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Biomanufacturing Capacity Crunch: It's The Supply Chain's Fault
What's behind the protracted biopharma manufacturing capacity crunch, when will it end, and what are manufacturers doing to keep supply on track? During Biotech Week in Boston ad BioProcess International, CDMOs and sponsors weighed in.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Explore the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential.
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Chemical modifications on CRISPR gRNAs enhance stability, editing efficiency, and reduce immune responses, enabling in vivo applications and clinical success.
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Explore a program focused on achieving process consistency through risk mitigation in four key areas: raw materials sourcing, equipment, manufacturing processes, and finished product testing.
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Explore the past, present, and future of supply chain security, ways the biopharma industry can secure supply chains and minimize risks, and more.
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The success of CGTs hinges upon adherence to specific logistics protocols. Learn how the integration of AI in the pharma supply chain is poised to enhance visibility, efficiency, and compliance.
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Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.